Does the next wave of opportunity for biosimilar drugs hold out good prospects for domestic drug companies?
An estimated $55 billion worth of biosimilar drugs are expected to go off patent by 2020, and this opens the floodgates for Indian drug companies to partner, develop and manufacture such products, said Charu Manaktala, Senior Medical Director and Head of Clinical Strategy, Strategic Drug Development with Quintiles Asia, a multinational clinical research organisation.
Tasted success Some Asian firms have already tasted success in the global landscape, she said, adding that companies are taking the development of their products to the global arena, rather than limiting themselves regionally.
Indian companies, though, will have to contend with Korean and Japanese companies who are active in this landscape.
Biosimilars are “highly similar” versions of an approved biological drug. They are complex, sensitive and difficult to make.
Second wave At least 160 biosimilars are in different stages of development for the top six selling biologics, said Manaktala, outlining the second wave of opportunity.
In fact, there are early signs of interest in the third wave of biosimilars as well, she added.
The products whose patents expire between 2015 and 2020 include Humira, Enbrel, Rituxan, MabThera, Avastin, Herceptin and Remicade. Companies of all hues, including traditional big pharma, generic drugmakers, biotech players and new entrants, are joining this biosimilar “stampede”, Quintiles said.
Pricing efforts Both the innovator companies and those that produce the biosimilar products are making every effort to capture the market, said Manaktala, referring to the trastuzumab example in India.
The breast cancer drug saw the innovator (Roche) drop price and partner with an Indian company to stave off competition from other Indian companies on the drug.
Similar pricing discounts and partnerships were seen in other markets as well, she indicated, citing an example in Norway where the biosimilar product Remsima was given at a 70 per cent discounted price in tender-driven purchases, from the initial discount of 40 per cent.
This pushed up the market share to 55 per cent from less than 10 per cent.
Evolving regulations The global regulatory environment on biosimilars too is constantly evolving, faster than any segment in pharmaceuticals. And, the coming year is likely to see a guidance from the US Food and Drugs Administration on the labelling of these products, as compared to the innovator’s products.
In the EU, where about 21 biosimilar products have been approved over the past decade, industry players point out that additional labelling was not required, said Manaktala.
China finalised its biosimilar guidelines in March and the Indian guidelines of 2012 too are in the process of revision, expected to be released for stakeholder review shortly, she said, outlining the global regulatory landscape.